Jobs at Syner-G

Support reliability, maintenance, and asset management for GMP pharmaceutical/biotech facilities. Improve PM programs, perform criticality assessments and RCAs, analyze failure data, use CMMS, recommend life-extension and spare-parts strategies, and collaborate cross-functionally to reduce downtime and improve asset availability.

Lead regulatory review and risk assessment of US and Canadian promotional materials across channels to ensure compliance with FDA/OPDP, Health Canada, and PAAB. Advise cross-functional teams on claim substantiation, evidence use, launch and lifecycle promotional strategy, support submissions/preclearance, deliver training, and monitor regulatory developments. Role involves stakeholder collaboration and may require extensive client travel.

Provide senior technical leadership for design, optimization, automation, and scale-up of bioprocess and manufacturing systems. Lead process strategy, commissioning, qualification, modeling, automation integration, multi-site transfers, vendor management, and mentor engineering teams to deliver robust, scalable processes across development, clinical, and commercial operations.

Lead development and implementation of a terminal sterilization program: define sterilization cycles and recipes, support commissioning/validation, ensure GMP and regulatory compliance, troubleshoot cycle development, train operations, and partner with CQV, engineering, and manufacturing to enable manufacturing readiness.

Lead business analysis, requirements definition, system administration, integration development, and reporting for enterprise systems and data initiatives. Partner with stakeholders to design solutions, manage user access, troubleshoot systems, support upgrades and migrations, and develop reporting in Kantata, NetSuite, Salesforce, and Power BI.

Serve as owners representative on large, complex lab/office or cGMP construction projects from design through commissioning. Write commissioning plans, review technical submissions, supervise subcontractor commissioning teams, coordinate equipment moves, ensure safety and cGMP compliance, use construction management software and CMMS, write SOPs, and close out projects with complete documentation and financial reconciliation.

Lead ~10 concurrent monoclonal antibody drug substance technology transfers from process handoff through GMP manufacturing, PPQ and commercialization. Provide MSAT technical leadership across upstream/downstream operations, develop governance and risk-based validation strategies, support commissioning/startup, drive portfolio reporting and resource planning, troubleshoot processes, and mentor engineering staff.

Lead regulatory strategy for clients across drug development stages, author and submit NDA/BLA/IND materials, manage FDA interactions (Type A/B/C), coordinate global submissions, evaluate manufacturing/quality impacts, mentor staff, and provide regulatory advice and industry thought leadership.

Lead Syner-G's West Coast biologics practice, drive business development, and personally deliver biologics CMC consulting across upstream/downstream/analytical/formulation. Author CMC regulatory submissions (INDs, BLAs), mentor staff, build regional team, and represent the firm at industry events. Role requires deep technical ownership and frequent client travel.

Manage construction and engineering capital projects from planning through commissioning and closeout. Coordinate contractors and A&E deliverables, maintain schedules and budgets, perform site walks, oversee commissioning and turnover of building systems, enforce safety and documentation standards, and act as owner's representative to ensure project delivery and regulatory/audit readiness.

Lead analytical development for oligonucleotide and peptide products across clinical phases: design, validate, and execute methods; perform characterization and stability testing; manage CDMO method transfers and comparability protocols; prepare regulatory submissions (IND/CTA); collaborate with CMC teams; mentor junior staff; and support project timelines and stakeholder communications.

Lead integrated Verification and Commissioning & Qualification (C&Q) programs for large GMP capital projects using ASTM E2500 principles. Manage scope, budget, schedule, resources, risks, and cross-functional teams through design, construction, startup, verification, system turnover, and operational handover. Oversee development and execution of verification plans, testing, documentation, and regulatory compliance while mentoring teams and supporting audits and client interactions.

Lead enterprise AI strategy, prioritize high-value use cases, and oversee end-to-end model development, MLOps, governance, deployment, and adoption. Build and mentor AI teams, partner with technology and business units, manage vendors and budgets, and measure business impact while ensuring responsible AI practices and stakeholder alignment.

Administer and improve the MRI Angus CMMS, plan and schedule preventive and corrective maintenance, support condition monitoring and RCFA, maintain asset hierarchies and spare parts, develop PM strategies and reliability metrics, train staff, and drive continuous improvement to support uninterrupted life-sciences facility operations.

General company overview and invitation to submit a general application for future roles across Syner-G. Applicants are encouraged to apply for consideration; the recruiting team will contact candidates when a suitable position opens.

Lead design, integration, commissioning, qualification, and startup of lyophilization systems for sterile vial manufacturing. Serve as technical lead for lyophilizer–aseptic filling integration, automation/SCADA/PLC interfaces, vendor coordination, IQ/OQ/PQ execution, troubleshooting, risk mitigation, and operational readiness while ensuring GMP/Annex 1 compliance and mentoring junior engineers.

Coordinate construction and maintenance project safety activities: organize pre-construction meetings, maintain schedules and safety documentation, review contractor safety submissions, support site walks and incident investigations, compile safety metrics, assist with contract administration, and enable cross-team communication to ensure compliance and hazard resolution.

Lead regional technical operations and account strategy for life-sciences client projects in the Southeast. Manage P&L, build and mentor engineering teams, drive client retention and business development, oversee project delivery for GMP laboratory and manufacturing facility design, construction, startup and operations, and collaborate with cross-functional teams to pursue growth and minimize risk.

Lead process optimization and commercial manufacturing support for oral solid dose (OSD) operations. Support tech transfer, troubleshoot process and yield issues, lead PPQ and continued process verification, collaborate with MSAT/Manufacturing/QA/Engineering, develop process documentation, analyze performance trends, support equipment qualification/start-up, and mentor junior engineers to drive throughput, yield, cost reduction, and GMP compliance.